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Активно (без набиране) Фаза 2 2024-515456-20-00

Hepatocellular Carcinoma on Cirrhosis With Child A/B7 and Hepatic Intra Arterial Injection of Idarubicin/Lipiodol Emulsion : Phase II, single arm, Multicentric

Фаза 2 – изследване на ефективността и дозировката
Заболявания: Hepato carcinoma cancer

Спонсор: Centre Hospitalier Universitaire De Montpellier

Налично на: БГ
Обобщение
Trial status: Authorised Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy., Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news., The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading, Tolérance defined by the NCI CTC AE v4.03 scale., Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle, The rate of thrombosis/hepatic arterial stenosis defined as the number of courses lasting which vascular thrombosis or stenosis is/are visible on arteriography initial hepatic artery(s), divided by the total number of cures., Overall survival defined as the time interval between the date of inclusion and the date of death (all causes). Patients alive without progression will be censored on the date of latest news. Disease control rate (partial, complete or stable response) at 4 months after the first cycle of chemo-lipiodol using mRECIST criteria.
Описание
Time until treatment failure defined as the time interval between the inclusion date and the date of treatment failure. Patients alive without treatment failure will be censored on the latest news date. Treatment failure is defined as progression, the appearance of toxicities, or the inability to administer chemotherapy., Progression-free survival: defined as the time interval between the date of inclusion and the date of first progression or death (whatever the cause). Patients living without progress will be censored on the date of the last news., The rate of patients in objective response (complete response or partial response) at 6 months to from the date of the first course of chemo-lipiodol according to the mRECIST criteria evaluated according to the investigator and centralized proofreading, Tolérance defined by the NCI CTC AE v4.03 scale., Quality of life questionnaire at 12 months after the first cycle of chemo-lipiodol at baseline, and 2, 4, 6, 12 months after the first cycle, The rate of thrombosis/hepatic arterial stenosis defined as the number of courses lasting which vascular thrombosis or stenosis is/are visible on arteriography initial hepatic artery(s), divided by the total number of cures., Overall survival defined as the time interval between the date of inclusion and the date of death (all causes). Patients alive without progression will be censored on the date of latest news.
Кой може да участва
Age group: 18-64 years, 65+ years Gender: Female, Male Target enrollment: 53 participants
Интервенции
LIPIODOL ULTRA FLUIDE 480 mg/ml, solution injectable
Drug
ZAVEDOS 10 mg, poudre pour solution pour perfusion
Drug
Места на провеждане 1
Франция (1)
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 2
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Здрави доброволци
Не
Начална дата
13.08.2024
Регистрационен номер
2024-515456-20-00
Източник
euclinicaltrials.eu
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